Oral Anticoagulant Apixaban for Treatment of Venous Thromboembolism (VTE)

A Pilot Study of an Oral Anticoagulant "Apixaban" for theTreatment of Venous Thromboembolism in Children and Adolescents

Patients who have developed a venous thrombosis will receive apixaban to treat and prevent a secondary thromboembolism.

Study Overview

• Status: Completed
• Conditions: Venous Thromboembolism
• Intervention / Treatment: Drug: Apixaban

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • Valhalla, New York, United States, 10595
      • New York Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children and adolescents with a newly diagnosed primary VTE.
• Treatment with apixaban has to begin within 72 hours of the diagnosis of VTE.
• Patients who have received heparin at the beginning of their diagnosis and are willing to switch to apixaban, are allowed to do so within 72 hours of their treatment. Patients who are switched to apixaban are not allowed to receive any other systemic anticoagulant therapy.
• VTE confirmed by diagnostic imaging.
• Children with body weight of ≥ 40 kg and are able to tolerate medication by mouth or administered via an NG or GT tube.
• Adequate liver function: AST and/or ALT <5 times ULN, and/or Direct bilirubin <2 times ULN
• Platelet count of at least ≥ 30,000/ul.
• Adequate renal function: >30% of GFR for age
• Female subjects of childbearing potential must not be nursing or pregnant with negative urine pregnancy test within 72 hours prior to dosing with study medication.
• Signed written informed consent

Exclusion Criteria:

• Current or recent (within 3 months) apixaban administration.
• Patient is unable to tolerate medications by oral route or by n/g administration, peptic ulcer disease, intestinal obstruction, toxic megacolon, typhlitis, or short gut syndrome.
• History of primary bleeding disorder and first degree family history of bleeding disorder.
• Active bleeding or high risk of bleeding at the time of study entry.
• History of significant head injury and/or any history of intracranial hemorrhage.
• Conditions predispose to intracranial bleed; e.g. brain tumor, brain metastasis.
• Uncontrolled Grade 3 or 4 severe hypertension.
• History of allergy to apixaban or factor Xa inhibitors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Abixaban; Apixaban 10 mg twice daily p.o. for seven days followed by 5 mg twice daily p.o. for children and adolescents weighting ≥40 kg who have been diagnosed with a thrombosis.	Drug: Apixaban; Apixaban 10 mg twice daily p.o. for seven days followed by 5 mg twice daily p.o. for children and adolescents weighting ≥40 kg; Other Names: Eliquis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
venous thromboembolism (VTE) formation	No new VTE	7-90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Doppler ultrasound vein imaging	Change in VTE on Doppler ultrasound	day 8-15

Collaborators and Investigators

• Sponsor: New York Medical College
• Investigators: Principal Investigator: Oya Tugal, MD, New York Medical College

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 2, 2017
• Primary Completion (ACTUAL): May 31, 2021
• Study Completion (ACTUAL): May 31, 2022

Study Registration Dates

• First Submitted: July 31, 2019
• First Submitted That Met QC Criteria: July 31, 2019
• First Posted (ACTUAL): August 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Apixaban
• Other Study ID Numbers: NYMC 191

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No